Effective from 6 April 2020, the Health Science Authority(HSA ) of Singapore has launched the new OSCAR system for Field Safety Corrective Action(FSCA).
Reporting and monitoring of FSCA have shifted from email to online system and currently, companies are required to register themselves through the OSCAR system.
Firstly, for the devices that are manufactured or supplied in Singapore, HSA requires a Notification Report (MDRR1 form ) to be submitted via OSCAR. This is then followed by a Final Report (MDRR2 form) within 21 days.
OSCAR system provides the online content of the forms for users.
On the other hand, for medical devices that are yet to be supplied in Singapore but registered via Special Access Route (SAR), users are required to submit a MDRR3 form within 30 days of initiating an FSCA.
HSA will also issue an acknowledgment of receipt of the FSCA report to the reporting person along with the actions to be taken.
Among the actions include labeling changes, the supply of CIP (correction in progress medical devices), recall and cease of supply.
A 3 months transitional period was provided to dealers to submit the FSCA report via the OSCAR system, however effective from the above date, HSA only accepts online submission.
For more information, please refer to
https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report